Kelly Thomas has more than 20 years of QA / QC leadership experience in the cGMP industry. She specializes in designing, implementing, and managing Quality Systems compliant with FDA, foreign regulatory agencies and the International Standards Organization (ISO). Her experience extends across a wide range of industries including Pharmaceutical, Biotech, Medical Device, and API.
Ms. Thomas’ leadership roles include Director of Quality Assurance / Quality Control. She has planned and supervised the start-up of new plant facilities and expansion projects, managed plant budgets, and established, staffed, and trained plant personnel. Ms. Thomas has also successfully developed, implemented and managed quality systems in both ISO and GMP facilities.
She has been a Guest Speaker at events and has published numerous articles on quality topics; including Environmental Monitoring, Managing FDA Inspections and Risk Management.